Senographe Pristina

K162268 · GE Healthcare · MUE · Nov 3, 2016 · Radiology

Device Facts

• Record ID: K162268
• Device Name: Senographe Pristina
• Applicant: GE Healthcare
• Product Code: MUE · Radiology
• Decision Date: Nov 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screenfilm systems.

Device Story

Full-field digital mammography (FFDM) system; utilizes X-ray image acquisition system and control station. Components include Cesium Iodide digital detector, X-ray tube, integrated high-voltage generator, and compression paddles. Operated by technologists in clinical settings; provides touch-screen interface for image acquisition, processing, and transfer. Redesigned for improved ergonomics (rounded shapes, soft armrests, thin breast support) and workflow (large workspace, sliding paddles). New gantry motorization allows independent compression and X-ray tube angulation; integrated generator reduces footprint. Radiologists review images to support breast cancer screening and diagnostic decision-making.

Clinical Evidence

Clinical image evaluation performed; expert radiologists assessed image quality in a clinical setting, confirming performance is good. No comparative statistical metrics (e.g., sensitivity/specificity) provided.

Technological Characteristics

FFDM system; Cesium Iodide digital detector; dual-track anode X-ray tube with silver filter; integrated high-voltage generator. Features improved ergonomic gantry with independent compression and tube angulation. Software-controlled acquisition and processing. Compliance with applicable safety and performance standards demonstrated.

Indications for Use

Indicated for screening and diagnosis of breast cancer in patients requiring mammographic imaging.

Regulatory Classification

Identification

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.

Predicate Devices

• Senographe Essential (P990066/S021)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 3, 2016

GE Healthcare % Mr. Gregory Pessato Regulatory Affairs Program Manager 283 rue de la Miniere Buc, 78530 FRANCE

Re: K162268

Trade/Device Name: Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 16, 2016 Received: August 17, 2016

Dear Mr. Pessato:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

### K162268

Device Name Senographe Pristina

Indications for Use (Describe)

Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screenfilm systems.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | August 5, 2016 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems SCS |
| Primary Contact Person: | Gregory Pessato<br>Regulatory Affairs Program Manager<br>GE Healthcare<br>283 RUE DE LA MINIERE<br>78530 BUC - FRANCE<br>Phone : + 33 1 30 70 93 16<br>Email : [e-mail] |
| Secondary Contact<br>Person: | Diane Uriell<br>Director of Regulatory Affairs, XR and Women's Health<br>GE Healthcare<br>Atlanta GA<br>Phone [phone]<br>Email:[e-mail] . |
| Device Trade Name: | Senographe Pristina |
| Common/Usual Name: | Full-field digital mammography system |
| Classification Names: | Full-field digital mammography system |
| | Class II CFR 892.1715 |
| Product Code: | MUE |
| Predicate Device(s): | Senographe Essential (P990066/S021) |
| Device Description: | Senographe Pristina is a new Full Field Digital Mammography (FFDM)<br>system. The system consists of an X-ray image acquisition system<br>dedicated to breast imaging and of a control station for image acquisition,<br>processing and display. The image acquisition system includes a Cesium<br>lodine digital detector, x-ray tube, integrated high voltage generator,<br>compression paddles. The control station provides a touch-screen user<br>interface to control image acquisition, image processing, and image<br>transfer. |
| Indications for Use: | Senographe Pristina generates digital mammographic images that can be<br>used for screening and in the diagnosis of breast cancer. Senographe<br>Pristina is intended to be used in the same clinical applications as<br>traditional film-based mammographic systems. |
| Comparison Of<br>Technological<br>Characteristics With The<br>Predicate Device: | Senographe Pristina uses the same fundamental technology as<br>Senographe Essential in terms of image acquisition (X-ray tube, detector,<br>image processing). Senographe Pristina includes a dual track anode with<br>silver filter, a Cesium lodine detector |
| | Senographe Pristina was redesigned using actualized components and<br>improved ergonomics. In particular Senographe Pristina was designed<br>with: |
| | Improved patient ergonomics (rounded shapes, soft armrests, thin<br>breast support) for improved patient comfort; |
| | Improved technologist ergonomics (large workspace, sliding implant /<br>small breast paddle) for better access to patient and eased patient<br>positioning; |
| | A new gantry motorization with independent compression and X-ray<br>tube head angulation for upgradability to 3D; |
| | Integrated X-ray generator for reduced footprint. |
| Determination of<br>Substantial Equivalence: | Senographe Pristina has the same indications for use as its predicate<br>device. It uses the same fundamental technology as Senographe Essential.<br>Differences between Senographe Pristina do not raise new questions of<br>safety and effectiveness. |
| | The impact of differences between the predicate and new device has been<br>assessed using applicable FDA Guidance and Standards. |
| | In particular the following testing was performed: |
| | Complete Image Quality Bench Performance testing was completed<br>showing appropriate performance. |
| | A Clinical image evaluation was performed showing that image quality<br>of Senographe Pristina in a clinical setting is good as assessed by expert<br>radiologists. |
| | Compliance was demonstrated against applicable safety and<br>performance standards. Successful System and Software verification and validation. |
| Conclusion: | Senographe Pristina is substantially equivalent to its predicate device<br>Senographe Essential. |

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